DDT-COA-000-163 Accelerating the FDA COA Qualification Plan for the PSYCHS as a ClinRO measure

DDT-COA-000-163 作为 ClinRO 措施，加快 PSYCHS 的 FDA COA 资格计划

• 批准号: 10836892
• 负责人: Catalina Valerie Mourgues-Codern
• 金额: $ 24.98万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-15 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10836892
• 关键词: DDT; COA; 000; 163; Accelerating

Abstract The clinical high-risk syndrome for psychosis (CHR-P) is a common psychiatric condition identified in the American Psychiatric Association’s Diagnostic and Statistical Manual (DSM-5). CHR-P primarily affects youth and young adults who exhibit multiple symptoms, including attenuated positive symptoms (delusions and hallucinations) that are distressing and impairing of daily activities. Clinical trials are urgently needed to develop specific and safe treatments for attenuated positive symptoms in CHR-P patients. An obstacle to the design and funding of these needed trials, however, is the absence of an FDA-qualified clinical outcome measure for use as the primary outcome upon which efficacy is assessed. A new instrument to measure the severity of attenuated positive symptoms, called the PSYCHS, has been recently developed as part of Foundation for the National Institutes of Health-funded Accelerating Medicines Partnership Schizophrenia observational study. The study is designed to prepare for future clinical trials supporting drug registration in CHR-P. The PSYCHS harmonizes two existing instruments extensively used in the field. A letter of intent to pursue qualification of the PSYCHS has been deemed reviewable by the FDA. The next step is to develop a Qualification Plan. The objective of the current application is to develop a comprehensive and robust clinical assessment outcome Qualification Plan for the PSYCHS. The current project will accelerate development of the Qualification Plan by: a) obtaining FDA input through a series of teleconferences and meetings; b) engaging academic experts, patients, and analytic resources to systematize current evidence supporting the conceptual suitability of the PSYCHS; and c) conduct preliminary qualitative studies to help develop the content validity section of the Qualification Plan.

摘要 精神病临床高危综合征（CHR-P）是一种常见的精神疾病， 美国精神病学协会的诊断和统计手册（DSM-5）。CHR-P主要影响青年 以及表现出多种症状的年轻人，包括减弱的阳性症状（妄想和 幻觉），这是痛苦和损害的日常活动。 临床试验是迫切需要开发具体和安全的治疗减弱阳性症状， CHR-P患者。然而，设计和资助这些必要的审判的一个障碍是缺乏一个 FDA合格的临床结局指标，用作评估疗效的主要结局。 一种新的测量减弱的阳性症状严重程度的工具，称为PSYCHS， 最近作为美国国立卫生研究院基金会资助的加速药物的一部分开发的 合作精神分裂症观察性研究。该研究旨在为未来的临床试验做准备 支持CHR-P的药物注册。PSYCHS协调了两个广泛使用的现有工具， 外地FDA认为寻求心理健康服务资格的意向书是可审查的。的 下一步是制定一个资格认证计划。本申请的目的是开发一种 PSYCHS的全面和稳健的临床评估结果鉴定计划。当前项目 将通过以下方式加快资格计划的制定：a）通过一系列措施获得FDA的意见 电话会议和会议; B）让学术专家、患者和分析资源参与系统化 支持心理健康和卫生服务概念适用性的现有证据;以及c）进行初步的定性研究。 研究，以帮助制定资格认证计划的内容有效性部分。